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Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease (REGISTRY-I)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557855
First Posted: March 20, 2012
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CardioDx
  Purpose
The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.

Condition Intervention
Coronary Artery Disease Angina Pectoris Chest Pain Cardiovascular Diseases Coronary Heart Disease CAD CVD CHD Diagnostic Test: Corus CAD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced Assessment of Chest Pain and Related Symptoms in the Primary Care Setting Through the Use of a Novel Personalized Medicine Genomic Test: Results From a Prospective Registry Study.

Resource links provided by NLM:


Further study details as provided by CardioDx:

Primary Outcome Measures:
  • Rate of referral vs. Corus CAD (ASGES) score as continuous variables [ Time Frame: 30 Days ]
    Composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA and/or to invasive cardiac catheterization occurring between Day 0 and Day 30 + 15 days.


Secondary Outcome Measures:
  • Rate of referral difference between low Corus CAD or ASGES (</=15) and non-low ASGES (>15) scores. [ Time Frame: 30 Day ]
    composite endpoint consisting of referrals to a cardiologist, to cardiac stress/CTA, and/or referral to invasive cardiac catheterization at Day 30 +15 days.


Enrollment: 342
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Diagnostic Test: Corus CAD
    Age/Sex/Gene Expression Score
Detailed Description:

This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD score as continuous variables.

Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:

  1. No further cardiac testing or treatment
  2. Medical therapy for angina or non-cardiac chest pain
  3. Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be enrolled at multiple qualified participating study centers that have incorporated Corus CAD (ASGES) for the diagnosis of obstructive CAD into their routine practice.
Criteria

Inclusion Criteria:

  1. Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
  2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

  1. History of myocardial infarction
  2. Current MI or acute coronary syndrome
  3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  4. Any previous coronary Revascularization
  5. Any individuals with:

    • Diabetes
    • Suspected unstable angina
    • Systemic infections
    • Systemic inflammatory conditions
  6. Any individuals currently taking:

    • Steroids
    • Immunosuppressive agents
    • Chemotherapeutic agents
  7. Recipient of any organ transplant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557855


Locations
United States, Arizona
Arizona Sun Family Medicine
Gilbert, Arizona, United States, 85296
Fiel Family Medicine
Tempe, Arizona, United States, 85283
United States, Georgia
Town Lake Internal Medicine
Woodstock, Georgia, United States, 30189
United States, Louisiana
Maringouin Medical Center
Maringouin, Louisiana, United States, 70757
The Bonin Clinic
Zachary, Louisiana, United States, 70791
United States, North Carolina
Triangle Primary Care
Wake Forest, North Carolina, United States, 27587
United States, Ohio
Comprehensive Physicians Associates
Youngstown, Ohio, United States, 44505
Sponsors and Collaborators
CardioDx
Investigators
Study Director: Michael Zapien, MS CardioDx
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CardioDx
ClinicalTrials.gov Identifier: NCT01557855     History of Changes
Other Study ID Numbers: CDX_000013
REGISTRY-I ( Other Identifier: CardioDx )
First Submitted: March 16, 2012
First Posted: March 20, 2012
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by CardioDx:
Corus CAD
ASGES
Age/Sex/Gene Expression Score
Gene Expression
GES
CAD
CVD
CHD
Precision Medicine
Clinical Utility
Registry
Coronary Artery Disease
Coronary Heart Disease
Cardiovascular Disease
Angina Pectoris
Chest Pain
Registry I
Registry-I

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Chest Pain
Angina Pectoris
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms